文档介绍：药品生产中计算机处理系统的验证指南
目录
I. INTRODUCTION 绪论
概述
硬件
A. Types 类型
1. Input Devices 输入设备
2. Output Devices 输出设备.
3. Signal Converters 信号转换器
4. Central Processing Unit (CPU) 中央处理单元
5. Distribution System 分布式系统
6. Peripheral Devices 外围设备
B. Key Points 关键点
1. Location 位置
2. Signal Conversion 信号转换
3. I/O Device Operation 输入/输出设备操作
4. Command Over-rides 指令中断
5. Maintenance 维护
C. Validation of Hardware 硬件确认
软件
A. Levels 分级
B. Software Identification 软件验证
C. Key Points 关键点
1. Software Development 软件升级
2. Software Security 软件安全
D. Validation of Software 软件确认
PUTERIZED OPERATIONS 计算机化操作
A. Networks 网络
B. Manual Back-up Systems 手动备份系统
C. Input/Output Checks 输入/输出检查
D. Process Documentation 过程文件
E. Monitoring puterized Operations 计算机化操作的监视
F. Alarms 报警
G. Shutdown Recovery 停止恢复
GUIDANCE CGMP 指导
A. Hardware 硬件
B. Software 软件
附录:
GLOSSARY 术语表
GUIDE TO INSPECTION OF
COMPUTERIZED SYSTEMS IN DRUG
PROCESSING
药品生产中计算机处理系统的验证指南
FEBRUARY, 1983
National Center for Drugs and Biologics
and
Executive Director of Regional Operations
I. INTRODUCTION 绪论
Computers are being used in increasing numbers in the pharmaceutical industry. As microprocessors e
more powerful, reliable, and less expensive we can expect the proliferation of this technology, with increasing
use by even very small pharmaceutical establishments.
在制药工业中,越来越多数量的计算机被使用。随着微处理器功能越来越强大,性能越来越稳定和价格
越来越便宜我们可以期待这个技术被更广泛应用,甚至越来越多的被用在非常小的制药设备。
Computer systems are used in a wide variety of ways in a pharmaceutical establishment, such as, maintenance
of quarantine systems for ponents, control of significant steps in manufacturing the dosage form,
control of laboratory functions, management of warehousing and distribution activities. Computer systems may
control one or more of these phases, either singly or as part of a highly automated plex.
计算机系统以多种多样的方式被用在制药设备中。例如,药品成分检疫系统的维持,制剂过程中重要步
骤的控制